MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-V

Device Problems Complete Blockage (1094); Fracture (1260); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Aaron m.Yengo-kahn, john c.Wellons iii, todd c.Hankinson, jason s.Hauptman, eric m.Jackson, hailey jensen, mark d.Krieger, abhaya v.Kulkarni, david.D.Limbrick jr., patrick j.Mcdonald, robert p.Naftel, jonathan a.Pindrik, ian f.Pollack, ron reeder, jay riva-cambrin, curtis j.Rozzelle, mandeep s.Tamber, william e.Whitehead, and john r.W.Kestle.Treatment strategies for hydrocephalus related to dandy-walker syndrome: evaluating procedure selection and success within the hydrocephalus clinical research network.Journal of neurosurgery pediatrics 28 (2021).Doi: 10.3171/2020.11.Peds20806.Objective treating dandy-walker syndrome¿related hydrocephalus (dwsh) involves either a csf shunt-based or endoscopic third ventriculostomy (etv)¿based procedure.However, comparative investigations are lacking.This study aimed to compare shunt-based and etv-based treatment strategies utilizing archival data from the hydrocephalus clinical research network (hcrn) registry.Methods a retrospective review of prospectively collected and maintained data on children with dwsh, available from the hcrn registry (14 sites, 2008¿2018), was performed.The primary outcome was revision-free survival of the initial surgical intervention.The primary exposure was either shunt-based (i.E., cystoperitoneal shunt [cps], ventriculoperitoneal shunt [vps], and/or dual-compartment) or etv-based (i.E., etv alone or with choroid plexus cauterization [cpc]) initial surgical treatment.Primary analysis included multivariable cox proportional hazards models.Results of 8400 hcrn patients, 151 (1.8%) had dwsh.Among these, the 102 patients who underwent shunt placement (79 vpss, 16 cpss, 3 other, and 4 multiple proximal catheter) were younger (6.6 vs 18.8 months, p <(><<)> 0.001) and more frequently had 1 or more comorbidities (37.3% vs 14.3%, p = 0.005) than the 49 etv-treated children (28 etvcpc).Fifty percent of the shunt-based and 51% of the etv-based treatments failed.Notably, 100% (4/4) of the dual compartment shunts failed.Adjusting for age, ba seline ventricular size, and comorbidities, etv-based treatment was not significantly associated with earlier failure compared with shunt-based treatment (hr for failure 1.32, 95% ci 0.77¿2.26; p = 0.321).Complication rates were low: 4.9% and 6.1% (p = 0.715) for shunt- and etv-based procedures, respectively.There was no difference in survival between etv-cpc¿ and etv-based treatment when adjusting for age (hr for failure 0.86, 95% ci 0.29¿2.55, p = 0.783).Reported events.- the overall failure rate was 50%.Notably, 100% of initial complex shunts failed.Of the shunt-based failures the causes are as follows: obstruction (41%), infection (16%), fracture (10%), over/underdrainage (functional) (8%), misplacement (2%), additional proximal catheter required (12%), and other (12%).About 80% of failures resulted in a simple shunt revision (i.E., replacement/revision of the single catheter system).Only 1 shunt was converted to an etv.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12392318
• MDR Text Key: 268943860
• Report Number: 2021898-2021-00156
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 08/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention